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Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.

To address secondary the investigators, will calculate the following proportion: (number of times patients refused to complete one or both questionnaires) / (number of questionnaire completion timepoints), and place a 95% confidence interval on the proportion.

WHO Oral Toxicity Scale/ChIMES Instrument [ Time Frame: 2 Years ]

To address secondary aim, the investigator, will analyze the data from the WHO Oral Toxicity Scale and the ChIMES instrument using the analytic methods specifically prescribed for these standardized instruments.

LLLT: The LLLT device will be positioned next to the face and neck for a total of 6 exposures: Right face, Midline face, Left face, Left neck, Midline neck, Right neck

Dose per anatomic site 50mW/cm2, 60 sec = 3.0J/cm2

Route: Extraoral

Total Treatment Time (all sites): 6 min

Schedule: Participants will be treated daily (including weekends and holidays) beginning on the first day of HCT conditioning and continuing through day +20 or hospital discharge if prior to day +20.

Evaluation: Participants will undergo formal mucositis and toxicity assessments at baseline and daily from day -1 through day +20, with a final assessment on the last day of treatment.

Device: Low Level Light Therapy

Other Name: THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)

Detailed Description:

This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients

OBJECTIVES:

Primary

Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT

Secondary

Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM

Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT

Eligibility

Information from the National Library of Medicine

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